Wound HealMOSAICNCT06600152
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
A study testing MAP Wound Matrix and DuoDerm in people with Wound Heal, run by Tempo Therapeutics at 3 sites in United States.
Trial summary
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs micrographic surgery (MMS) compared to control. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- MAP Wound Matrix and DuoDerm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Aug 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to undergo the written informed consent process prior to enrollment in this study.
- At least 22 years of age at screening.
- Has non-melanoma skin cancer and be scheduled for skin cancer surgery with Mohs micrographic surgery on a location suitable for secondary intention healing.
- Resulting surgical wound after Mohs micrographic surgery must be at least 1 cm and no more than 4 cm in diameter (or surface area of at least 0.8 cm2 and no more than 12.6 cm2).
- Resulting surgical wound after Mohs micrographic surgery must be full thickness.
- Willing to return for all required follow-up visits.
- Willing to follow the instructions of the Principal Investigator.
Who cannot join
- Has a confirmed diagnosis of clinically significant peripheral neuropathy.
- Has uncontrolled Type I or Type II diabetes and HbA1c values greater than 8.0% within the last 6 months.
- Has a known infection in the area of the Mohs micrographic surgery.
- Has a known allergy to any of the components of the TT101 Device.
- Is an active daily cigarette smoker.
- Is pregnant or lactating.
Show all 12Show fewer
- Is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner).
- Has clinical evidence of Peripheral Vascular Disease (PVD) in the form of grade 2 pitting Edema or higher.
- Has been diagnosed with a surgical or wound site infection within the last 6-months.
- Has been diagnosed with chronic ulcer or wound within the last 12- months.
- Has a remote active infection concurrent with having the Mohs micrographic surgery.
- Per Investigator's discretion the subject is not appropriate for inclusion in the trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Studies in Dermatology
Cypress, Texas, 77429
Cal Coast Dermatology
Encino, California, 91436
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, 46260
About this study
Official title: A Randomized, Open-label, Investigational Safety Evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) Device as a Volumetric Biomaterial Scaffold Applied to Clean Wounds After Skin Cancer Surgery With Mohs Micrographic Surgery (MMS) Compared to Control.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs micrographic surgery (MMS) compared to control.
- Conditions
- Wound Heal
- Being tested
- MAP Wound Matrix, DuoDerm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP Wound MatrixDevice
The MAP Wound Matrix is indicated for the management of full thickness wounds, including surgical sites, donor skin graft sites, wound dehiscence, lacerations, and draining wounds. The application of MAP Wound Matrix will occur immediately after Mohs surgery once hemostasis has been achieved
DuoDermDevice
DuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately following Mohs surgery according to the manufacturer\'s instructions.
| Study group | Role | What they receive |
|---|---|---|
| Microporous Annealed Particle (MAP) Wound Matrix | Experimental | The Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS). Receives: Device: MAP Wound Matrix |
| Hydrocolloid dressing (DuoDerm) | Active comparator | A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery. Receives: Device: DuoDerm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group.
Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.
Measured: Week 0 (treatment) up to Week 24 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Aug 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization model.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tempo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Quach, BS, Study director, Tempo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600152
- Sponsor's protocol ID
- TT-CLN-004-03
- Acronym
- MOSAIC
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2024
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Hau JT, Martin SJ, Roosa CA, Deshayes S, Hanke CW. Microporous Annealed Particle Wound Matrix for Post-Mohs Defects: A Randomized Controlled Multicenter First-In-Human Study. Dermatol Surg. 2026 Aug 11. doi: 10.1097/DSS.0000000000005306. Online ahead of print.
PubMed 42574233
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Investigational Safety Evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) Device as a Volumetric Biomaterial Scaffold Applied to Clean Wounds After Skin Cancer Surgery With Mohs Micrographic Surgery (MMS) Compared to Control.
- ClinicalTrials.gov ID
- NCT06600152
- Acronym / sponsor ID
- MOSAIC / TT-CLN-004-03
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tempo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs micrographic surgery (MMS) compared to control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization model.
| Arm | Type | Receives |
|---|---|---|
| Microporous Annealed Particle (MAP) Wound Matrix | Experimental | Device: MAP Wound MatrixThe Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS). |
| Hydrocolloid dressing (DuoDerm) | Active comparator | Device: DuoDermA hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to undergo the written informed consent process prior to enrollment in this study.
- At least 22 years of age at screening.
- Has non-melanoma skin cancer and be scheduled for skin cancer surgery with Mohs micrographic surgery on a location suitable for secondary intention healing.
- Resulting surgical wound after Mohs micrographic surgery must be at least 1 cm and no more than 4 cm in diameter (or surface area of at least 0.8 cm2 and no more than 12.6 cm2).
- Resulting surgical wound after Mohs micrographic surgery must be full thickness.
Key exclusion criteria (12 listed)
- Has a confirmed diagnosis of clinically significant peripheral neuropathy.
- Has uncontrolled Type I or Type II diabetes and HbA1c values greater than 8.0% within the last 6 months.
- Has a known infection in the area of the Mohs micrographic surgery.
- Has a known allergy to any of the components of the TT101 Device.
- Is an active daily cigarette smoker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAP Wound MatrixThe MAP Wound Matrix is indicated for the management of full thickness wounds, including surgical sites, donor skin graft sites, wound dehiscence, lacerations, and draining wounds. The application of MAP Wound Matrix will occur immediately after Mohs surgery once hemostasis has been achieved | Device | Microporous Annealed Particle (MAP) Wound Matrix |
| DuoDermDuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately following Mohs surgery according to the manufacturer\'s instructions. | Device | Hydrocolloid dressing (DuoDerm) |
Primary outcome
Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group.
Time frame: Week 0 (treatment) up to Week 24 (End of Study)
Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42574233Hau JT, Martin SJ, Roosa CA, Deshayes S, Hanke CW. Microporous Annealed Particle Wound Matrix for Post-Mohs Defects: A Randomized Controlled Multicenter First-In-Human Study. Dermatol Surg. 2026 Aug 11. doi: 10.1097/DSS.0000000000005306. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Quach, BS study director
Tempo Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP Wound Matrix and DuoDerm in people with Wound Heal, run by Tempo Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group. (time frame: Week 0 (treatment) up to Week 24 (End of Study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06600152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.